From the FDA requirements to the developing of better drugs and treatments. Discover the reasons to Diversify Clinical Trials.

1. Reasons to Diversify
Clinical Trials

2. Reasons to Diversify
Clinical Trials
1. FDA Regulations
2. Health Disparities
3. Underrepresentation
4. Evaluate Effectiveness
5. Clinical Trials Still Don't Reflect the Diversity of America
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3. FDA Action Plan
Section 907 of the FDA Safety and Innovation Act of
2012 also includes recommendations for improving
the completeness and quality of analyses of data on
demographic subgroups.

4. Health Disparities
People’s bodies process drugs in very different ways.
Racial and ethnic categories can serve as a proxy for
those differences.
An evidence of these disparities is when African-
Americans and Puerto Ricans don’t respond as well to
some of the most common asthma controller
medications, and that’s really a tragedy since these two
groups are the most affected by asthma in the United
States.

5. Under Representation
Seventy-seven studies were reviewed
and 52 met our inclusion criteria. Of
these, only 85% reported gender and
21% reported ethnicity.
Women in some cardiovascular trials
and general inclusion of black/African-
American and minority participants in
clinical trials. This is the fact why under
representation is one of the reasons to
diversify clinical trials.

6. Evaluate Effectiveness
◦ Provide a critical base of evidence for evaluating whether a medical product is effective
on a specific ethnic, age or gender from the demographic spectrum before the product
is approved for marketing.
◦ The composition of the population enrolled in a trial should help FDA reviewers,
clinicians, or policy makers to have confidence that the trial results will apply to future
practice in everybody.

7. Clinical Trials
Still don’t Reflect the Diversity of America
According to a 2011 report from the conference
“Dialogues on Diversifying Clinical Trials,” sponsored
by FDA’s Office of Women’ s Health and the Society
for Women’s Health Research and supported by the
Office of Minority Health (OMH):
• African Americans represent 12% of the U.S.
population but only 5% of clinical trial
participants
• Hispanics make up 16% of the population
but only 1% of clinical trial participants
In 2012 the NIH reported the following numbers for minorities
enrollment in their studies.

8. CONCLUSIONS
Researchers are being called for diversification among the committees that review grant
applications, and evaluating minority recruitment as one criterion in determining the scientific
merit of studies.
As the U.S. becomes more diverse these gaps are more important to fill — and could help make
a dent in the estimated $300 billion lost each year because of health disparities.
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9. About FOMAT Medical Research
FOMAT Medical Research is pioneering Clinical Research in Ecuador, Colombia, Peru and
Latin America. We are directing the Clinical Research Departments for several of the largest
hospitals throughout the Americas.
In Latin America, FOMAT is acknowledged as a Site Management Organization (SMO) with local
Contract Research Organization (CRO) capabilities.
Diversifying Clinical Research is a top priority at FOMAT, which is why collecting data from
Hispanic Sites is essential. Data is gathered through our numerous clinical sites, located in
Ecuador,the United States, Colombia and Peru.